DE202016002787U1 - Device for preventing misinsertion of a drug - Google Patents

Abstract

Device for preventing the delivery of a drug via a liquid-flowable connection from the drug unit (4) to the patient (20), attachable to a drug delivery device (5), comprising - a readout unit (3) for collecting the data of the identification means (7) of the drug unit ( 4) and the identification means (9) of the patient (20) and for forwarding this data to the control unit (2), - a contact measuring means (8) for detecting whether a drug unit (4) is coupled to a drug administration device (5) and the Forwarding of this data to the control unit (2), - a control unit (2) for detecting and evaluating the data of the readout unit (3), for detecting and evaluating the data of the contact measuring means (8), for exchanging data with a database (6) and for processing these data and for controlling the closure unit (1) and - a closure unit (1) for a closure (1a) suitable for closing and opening the liquid-throughflowable connection, characterized in that the control unit (2) acts on the closure unit (1) such that the closure (1a) is opened only when - the contact measuring means (8) has detected the coupling of a drug unit (4) to the drug delivery device (5) and forwarded this data to the control unit (2), - and when the readout unit (3) detects the data of the identification means (7) and (9) and has passed on to the control unit (2), - and if the control unit (2) has compared the forwarded data with the data of the database (6) and has established a compatibility between the data of the identification means (7) and (9).

Description

The present invention relates to a device for preventing a misfeed of a drug via a liquid-permeable compound from the drug unit to a patient (human or animal). A medicinal product (synonym: medicament) is a substance or composition of matter intended to heal or prevent human or animal diseases. A drug unit is a container suitable for containing a drug filled with a drug. Each drug unit must be provided with information on the medicinal product it contains. Examples of a drug unit are transfusion units (containing a blood product as a drug) or infusion units (containing an infusion solution as a drug).

Flowable drugs, such as blood products or infusion solutions, may be administered to the patient via a fluid-permeable compound, such as via a venous indwelling catheter. The liquid-permeable compound may also be a tube (eg, nasogastric tube), a tube (eg, a rigid endoscope), or another catheter (eg, urinary bladder catheter).

Misdirection of a drug is present unless the medically indicated and prescribed drug is administered to the patient via a liquid-infusible compound. Examples are a false transfusion or a misinfection.

Transfusion is the administration of a blood product. Mis-transfusion occurs when the medically prescribed blood transfusion unit with the medically-indicated blood product is not administered to the patient in question, but an incorrect transfusion unit with a non-medically indicated blood product. The wrong transfusion unit is also referred to as any transfusion unit that can lead to incompatibility.

An infusion is the administration of an infusion solution. A misinterfusion occurs if the medically indicated infusion unit with the medically indicated infusion solution is not administered to the patient in question, but an incorrect infusion unit with a non-medically indicated infusion solution. The wrong infusion unit is also referred to as each infusion unit, which can lead to incompatibility.

Blood products and infusion solutions are medicines that are administered to the patient in question, according to medical indications and on the instructions of the doctor. In this case, it is essential that the medically prescribed blood product in the transfusion unit or the medically prescribed infusion solution in the infusion unit is actually administered to the relevant patient so that there are no incompatibilities. Incompatibility can cause serious side effects in the patient and lead to death in particularly severe cases.

The present invention is suitable both for use in human medicine and in veterinary medicine. The present invention is equally suitable for both transfusion and infusion units, thus preventing false transfusions and misinfections. The present invention is equally suitable for preventing a misfeed of any flowable drug, so it generally prevents any misinsertion.

definitions

If the drug unit is an infusion unit or transfusion unit, then the same definitions apply mutatis mutandis.

Attachment of a drug unit (coupling): Spatial coupling of the drug unit to a liquid-permeable compound. The attachment (coupling) thus causes the drug unit to be connected to the patient via a fluid-permeable compound and therefore the drug can flow into the patient. The term "coupled in" refers to the state that a drug unit is connected to the liquid-permeable connection. In the case of a transfusion, a transfusion unit is coupled as the drug unit to the transfusion device as a special form of a liquid-throughflowable connection. In the case of an infusion, an infusion unit is coupled as the drug unit to the infusion device as a special form of a liquid-permeable connection. The coupling may be, for example, pushing the mandrel of the transfusion machine into the blood bag, or opening a three-way stopcock or screwing the transfusion tube to the venous indwelling catheter. It is known to the person skilled in the art that there are still further possibilities for the spatial coupling of the drug unit to the patient.

Suspension of a drug unit (decoupling): Spatial decoupling of the drug unit from a fluid-permeable compound. Depositing (decoupling) thus causes the drug unit to be removed from the patient and, therefore, the drug is not in the patient can stream. In the case of a transfusion, a transfusion unit is decoupled from the transfusion device as a special form of a liquid-throughflowable connection as the drug unit. In the case of an infusion, an infusion unit is decoupled from the infusion device as a special form of a liquid-throughflowable connection as the drug unit. The decoupling may be, for example, pulling the mandrel of the transfusion machine out of the blood bag, or closing a three-way stopcock or unscrewing the transfusion tube from the venous indwelling catheter. It is known to the person skilled in the art that there are further possibilities of spatial decoupling of the medicament unit from the patient.

Blood product: Blood, blood components, blood components, blood preparations or serums, which are obtained, portioned, stored and transfused for medical purposes and are intended for the manufacture of active substances or medicaments. Blood products may be whole blood, red blood cell concentrate, platelet concentrate, granulocyte concentrate, fresh frozen blood, fresh frozen plasma, FFP, GFP, lyophilized blood plasma or blood serum, or combinations thereof, as well as mixtures of blood or blood components with other pharmaceutically and medically acceptable substances, for example, anticoagulants , Blood products are produced by the blood donation of one or more blood donors (humans or animals). Blood products are recovered, portioned and stored in suitable containers, such as blood bags, blood bottles or syringes, and are usually intravenously (i.v.) administered to a patient (human or animal) via a venous indwelling catheter. Each blood product is marked by a label and a defined barcode (Eurocode or ISBT code) which is attached to the container, as well as additionally by a consignment note (canning note) worldwide uniquely, permanently and unmistakably.

Transfusion: transmission of blood products to a patient (human or animal) for medical indication. The blood product is usually filled in a blood bag, or in a blood bottle or in a syringe as a drug unit. The administration (administration, transfusion) is usually intravenous (i.v.) via a venous indwelling catheter. The drug unit (also called a transfusion unit in the case of a transfusion) with the blood product is usually connected to the venous indwelling catheter via a transfusion machine or a transfusion device or a transfusion tube. The blood products may also be administered (transfused) to the patient by a transfusion device or a transfusion or perfusion pump (eg syringe pump) from the drug unit via the transfusion tube and the venous indwelling catheter.

Transfusion series: Within the framework of a treatment cycle, a patient (human or animal) transfuses more than one drug unit with a blood product as a drug immediately after one another.

Solution for infusion: Liquid medicines for parenteral use in the patient (human or animal). Infusion solutions are liquids that are either themselves medicinal or contain one or more drugs. Examples are electrolyte solutions, colloidal solutions, glucose solutions or osmotherapeutics. Infusion solutions are also drugs that are diluted or dissolved in one of these solutions. Examples are antibiotic solutions or chemotherapeutic solutions.

Infusion: Transfer of infusion solutions to a patient (human or animal) for medical indication. The infusion solution is usually filled in an infusion bag, or in an infusion bottle or in a syringe as a drug unit. The administration (administration, infusion) is usually intravenous (i.v.) via a venous indwelling catheter. The drug unit (also called an infusion unit in the case of an infusion) with the infusion solution is usually connected to the venous indwelling catheter via an infusion machine or an infusion device or an infusion tube. The infusion solutions can also be administered (infused) to the patient by an infusion device or an infusion or perfusion pump (eg syringe pump) from the drug unit via the infusion tube and the indwelling catheter.

Series of infusions: In the course of a treatment cycle, a patient (human or animal) is infused with one infusion solution, one after the other, in one unit of medication.

Incompatibility: Primarily incompatibility means a blood group incompatibility (blood group incompatibility), ie the blood groups of the blood product do not match with the blood groups of the patient receiving a transfusion. This is especially relevant in the ABO blood group system of humans. Incompatibilities may also be present in any other blood group or blood group system in humans and animals. Incompatibilities may also be present if the shelf life of the blood product or infusion solution in question has expired or there is a wrong medical indication for transfusion or infusion. The term is therefore applicable to all types of medicines, in particular Blood products and infusion solutions are applicable if a wrong drug unit (eg transfusion or infusion unit) is administered to the patient (human or animal). In the sense of this invention, an incompatibility always occurs when a misfeed of a drug takes place. The opposite of incompatibility is compatibility.

Fluid-permeable connection: all of the devices which are suitable for the production of a fluid-permeable connection between the drug unit and the patient (human or animal). This set of devices is called a drug delivery device and is a form of liquid-permeable compound. The liquid-permeable compound allows the drug to flow from the drug unit into the patient. In the case of a transfusion, the liquid-permeable compound is realized by the transfusion device. Here, the blood product flows from the transfusion unit via the transfusion device into the patient. In the case of an infusion, the liquid-permeable compound is realized by the infusion device. Here, the infusion solution flows from the infusion unit via the infusion device into the patient. For example, tubing, tubes, valves, taps, branches or junctions, transfusion devices, transfusion devices, infusion devices, infusion sets, transfer devices, transfusion pumps, perfusion pumps, infusion pumps, syringe pumps, transfusion tubes, infusion tubes, extension tubes, three-way valves and venous indwelling catheters (peripheral or central venous indwelling catheters) , The drug delivery device comprises at least one of these components or also several thereof. The most essential components of a transfusion device are the transfusion device (transfusion set) and the transfusion pump. They ensure a continuous and controllable transfusion volume per unit of time. The use of a pump is not mandatory, because the blood product can also be moved by gravity into the patient. The most important components of an infusion device are the infusion set (infusion set) and the infusion pump. They ensure a continuous and controllable infusion volume per unit of time. The use of a pump is not mandatory, because the infusion solution can also be moved by gravity into the patient.

The prescribed drug may be administered to the patient only if the fluid-permeable compound is arranged to allow passage of the drug through all components of the drug delivery device. The liquid-throughflowable compound must therefore be open in order to carry out a drug delivery (eg a transfusion or an infusion).

The drug delivery device is usually suspended on a suitable stand or stand (eg, transfusion stand, IV pole) when the drug is to be delivered by gravity into the patient. But it is also possible with the help of a syringe pump (for example, perfusor) or another pump to pump the drug into the patient. In that case, the drug delivery device may be attached to the patient in any manner. It is only important that the liquid flow-through compound is open along the entire length from the drug unit to the patient when the drug is to be administered.

State of the art

• – Aufklärung des betreffenden Patienten über Nutzen und Risiken der Transfusion.
• – Vorbereitung der Transfusion: Das ärztliche Personal überprüft, ob die vorgesehene Transfusionseinheit für den betreffenden Patienten bestimmt ist und ob die Blutgruppen des vorgesehenen Blutproduktes den Blutgruppen des betreffenden Patienten entsprechen. Ebenso überprüft das ärztliche Personal das Verfalldatum (Haltbarkeitsdatum) und die Unversehrtheit der Transfusionseinheit sowie die Gültigkeit der Verträglichkeitsprobe. Das ärztliche Personal überprüft auch die Personalien des Patienten mit Hilfe der Krankenakte und vergleicht den Original-Blutgruppenbefund mit dem Blutgruppenbefund auf dem Begleitschein und dem Anforderungsschein.
• – AB0-Bedside-Test (AB0-Identitätstest): Bei der Transfusion von Erythrozytenkonzentraten oder Vollblut wird unmittelbar vor der Transfusion vom ärztlichen Personal ein AB0-Bedside-Test am betreffenden Patienten durchgeführt und das Ergebnis schriftlich dokumentiert.
• – Anhängen der Transfusionseinheit: Die Transfusion von Blutprodukten erfolgt üblicherweise über ein geeignetes Transfusionsgerät, welches ein Teil der Transfusionsvorrichtung ist. Dieser Schritt wird vom ärztlichen Personal oder vom Pflegepersonal durchgeführt.
• – Start der Transfusion durch Einschalten des Transfusionsgerätes bei geöffneter Transfusionsvorrichtung. Dieser Schritt wird vom ärztlichen Personal oder vom Pflegepersonal durchgeführt.
• – Abhängen der Transfusionseinheit: Wenn das Blutprodukt zur Gänze oder auch nur teilweise dem Patienten verabreicht wurde, dann wird die Transfusionseinheit von der Transfusionsvorrichtung entkoppelt. Dieser Schritt wird vom ärztlichen Personal oder vom Pflegepersonal durchgeführt.
• – An- und Abhängen weiterer Transfusionseinheiten (Transfusionsserie): Bei Bedarf wird dieser Schritt vom ärztlichen Personal oder vom Pflegepersonal durchgeführt.
• – Dokumentation aller durchgeführten Schritte sowie von Nebenwirkungen in der Krankenakte. Dieser Schritt wird vom ärztlichen Personal oder vom Pflegepersonal durchgeführt.
• – Aufbewahrung aller verwendeten Transfusionseinheiten (vollständig geleert oder teilentleert) für weitere Untersuchungen im Rahmen der Qualitätskontrolle. Dieser Schritt wird vom ärztlichen Personal oder vom Pflegepersonal durchgeführt.

The delivery of a drug through a fluid-infiltratable connection to a patient is regulated and defined in work or service instructions for the medical staff. A transfusion as a special form of drug delivery is carried out according to the prior art in the following steps:

• - educate the patient about the benefits and risks of transfusion.
• - Preparation of the transfusion: The medical staff will check whether the intended transfusion unit is intended for the particular patient and whether the blood groups of the intended blood product correspond to the blood type of the patient concerned. The medical staff will also check the expiry date and the integrity of the transfusion unit and the validity of the tolerability sample. The medical staff also checks the personal details of the patient with the help of the medical record and compares the original blood group findings with the blood group findings on the consignment note and the request form.
• - AB0 bedside test (AB0 identity test): In the case of transfusion of red blood cell concentrates or whole blood, the ABO bedside test is performed on the patient in question immediately before the transfusion and the result is documented in writing.
• Attaching the transfusion unit: The transfusion of blood products usually takes place via a suitable transfusion device, which is part of the transfusion device. This step is performed by the medical staff or nursing staff.
• - Start the transfusion by switching on the transfusion device when open Transfusion device. This step is performed by the medical staff or nursing staff.
• Depositing the transfusion unit: If the blood product has been administered wholly or only partially to the patient, then the transfusion unit is decoupled from the transfusion device. This step is performed by the medical staff or nursing staff.
• - Attachment and removal of further transfusion units (transfusion series): If necessary, this step is carried out by the medical staff or nursing staff.
• - Documentation of all performed steps as well as side effects in the medical record. This step is performed by the medical staff or nursing staff.
• - Storage of all transfusion units used (completely emptied or partially emptied) for further quality control studies. This step is performed by the medical staff or nursing staff.

Despite regulations governing the delivery of drugs via a fluid-infiltratable connection to a patient, misconducts due to incompatibilities are common, primarily due to human error by the medical staff. First of all, false transfusions are a serious medical problem as they cause potentially fatal complications. The cause of mismanagement is in most cases human error: patients or transfusion units are confused, especially in hectic situations in the shock room, in the emergency room, in the intensive care unit or in complications during surgery. It is known that numerous transfusions occur during later transfusions in the course of a transfusion series and only rarely in the first transfusion of a transfusion series. It is well-known that despite the latest technology and various security measures regularly fatal false transfusions continue to happen in German, European and international hospitals due to confusion of blood products.

It is a general effort to avoid false transfusions as much as possible. For this purpose, guidelines for the blood donation and transfusion system have been developed, which regulate every procedural step from the blood donor to the patient. The process steps for obtaining and labeling blood products are extremely safe, and only in very rare cases human error occurs. In the application of blood products, so the transfusion itself, human error due to the circumstances (shock room, emergency room, surgery, intensive care unit) is more likely.

Likewise, this prior art relates to various types of infusions, particularly those containing individually customized infusion solutions with customized drug compositions. An example of this is an infusion of a patient-specific composition of chemotherapeutic agents in a patient with a tumor disease. This prior art is generally applicable to all drug delivery lines via a liquid-permeable compound.

There are various methods for preventing false transfusions. They are based on first securing the identity of the patient and the blood product by a medical employee and then reconciling the obtained identity data. Thus, the data of the patient are compared by a medical employee with the data of the blood product and in case of a detected incompatibility, the transfusion is stopped or not started by a medical employee. This means that a medical employee must independently or independently stop the transfusion or may not start. If this medical employee makes a mistake, then this leads almost inevitably to a misinsertion (false transfusion).

Compatibility between the patient and the blood product is checked by comparing the data in the patient's medical record with the blood product data on the Transfusion Unit Transit Certificate. This test is performed by authorized medical staff and should be done immediately before starting the transfusion. In general, the medical staff compares the patient blood groups determined by a laboratory employee in the blood bank with the blood group information on the blood product slip. This should recognize the medical staff confusion.

In the Transfusion of whole blood, erythrocyte or granulocyte concentrate, the medical staff also checks the compliance of the patient blood groups of the AB0 system using an ABO bedside test (AB0 identity test) and documents the test result in the medical record. Subsequently, the medical staff decides on the compatibility, especially with regard to the AB0 system.

Performing the ABO bedside test is a common procedure for avoiding AB0 incompatibilities in Germany and France and is based on the blood group test principle. In the AB0 bedside test, an AB0 confirmatory test is performed on a certified test slide just prior to the start of transfusion of whole blood, red cell or granulocyte concentrate with the patient's blood to verify the actual AB0 blood group of the patient immediately prior to transfusion. However, only one ABO incompatibility can be detected. This limitation is due to the working principle of the AB0 bedside test as an AB0 confirmatory test.

The known ABO bedside tests can detect incompatibility only in the false transfusion of whole blood, erythrocyte or granulocyte concentrate, but not in the false transfusion of other blood products, and not at all in miscarriage or miscarriage in general. In addition, the known AB0 bedside tests can not be automated and must be performed by medically trained staff. This is time consuming and costly and prone to human error.

To secure the identity of the patient are increasingly patient barcodes, which are located for example on arm or footbands or biometric systems in use. For a clear identification of the patient is possible, and this identification can also be automated.

According to the current state of the art, therefore, the medical staff of the blood bank, the laboratory and the transfusion-authorized medical staff (eg doctor in the trauma room) must communicate a large number of data relating to the blood product and the patient in question in order to avoid false transfusion.

Current control procedures to avoid incompatibility (eg, ABO bedside test) do not prevent a blood product whose shelf life has expired and therefore may no longer be transfused from being transfused due to a human error. This form of incompatibility can cause as serious adverse health effects as blood group incompatibility.

In all current control procedures to avoid incompatibility (eg ABO bedside test), the medical staff involved must themselves detect the presence of an incompatibility and actively interrupt or not start the transfusion. That is, human errors can lead to a false transfusion, even if the identity of the patient and the blood product to be administered has been correctly established. These human errors are the cause of the most common adverse effects of transfusion and may even lead to death in the event of AB0 incompatibility.

The medical staff involved must have medical knowledge of blood group compatibility and, after aligning patient and blood product data, identify incompatibility and make a correct decision. However, this does not prevent inadvertent transfusion of an incompatible blood product, for example as part of a series of transfusions, during hectic situations or by a non-authorized employee. The attachment and detachment of a transfusion unit by a non-authorized employee is a particularly serious human error, because it is usually not recognized, or is only recognized if the incompatible blood product has already been transfused.

Human transfusion failure is possible at any time, despite numerous and complex control procedures, and has even increased in recent years. This potentially fatal error, namely the transfusion of the incompatible blood product on a correctly identified patient, can so far only be prevented by individual controls. To avoid false transfusions, medical staff must perform numerous transfusion transfusion controls on each individual transfusion unit and decide on compatibility, especially AB0 compatibility, for each individual transfusion unit. This approach is prone to error especially in the medical field with frequent staff turnover, emergency situations and unresponsive, unconscious or disoriented patients.

A special feature is the transfusion of blood products in patients whose blood groups have not yet been determined, for example due to special emergencies. In these cases, only blood or blood products with the blood group 0 may be transfused (ie universal blood products) in order to avoid a potentially fatal hemolytic transfusion reaction. In these cases, the medical staff is therefore required in a special way, because it must both register that the blood type of the patient in question are still unknown and also draw the correct conclusion that in this case only blood or blood products with the blood group 0 transfused be allowed to.

task

The object of the present invention is to provide a device for preventing a misfeed of a drug via a liquid-permeable compound. In particular, a device is to be made available with which a false transfusion or a misinfection reliable, simple and be prevented autonomously. Likewise, with the present invention, it should also be ensured reliably, simply and autonomously that only blood products with the blood group 0 are transfused with still unknown patient blood groups (for example in the case of an emergency) (AB0-universally compatible transfusion).

Solution of the task

The object of the invention is achieved by the claim. 1

The following solution of the task mainly refers to transfusions. However, it is analogously applicable to various types of infusions or to the administration of medicaments in general.

• – eine Ausleseeinheit 3 zur Erfassung der Daten des Identifikationsmittel 9 des Patienten 20 und des Identifikationsmittel 7 der Arzneimitteleinheit 4 und zur Weiterleitung dieser Daten an die Steuereinheit 2;
• – ein Kontaktmessmittel 8 zur autonomen Erfassung, ob eine Arzneimitteleinheit 4 an einer Arzneimittelverabreichungsvorrichtung 5 angekoppelt ist und zur Weiterleitung dieser Daten an die Steuereinheit 2. Das Kontaktmessmittel 8 erfasst also autonom jedes An- und Abhängen (jeden Wechsel) einer Arzneimitteleinheit 4, das heißt, es erfasst das Angekoppeltsein einer Arzneimitteleinheit 4;
• – eine Steuereinheit 2 zur Erfassung und Auswertung der Daten der Ausleseeinheit 3, zur Erfassung und Auswertung der Daten des Kontaktmessmittels 8, zum Austausch von Daten mit einer Datenbank 6 und zur Verarbeitung dieser Daten sowie zur Steuerung der Verschlusseinheit 1. Die Steuereinheit 2 erfasst also die Daten des Identifikationsmittels 9 des Patienten 20, die Daten des Identifikationsmittels 7 der Arzneimitteleinheit 4 sowie die Daten des Kontaktmessmittels 8 bezüglich jedes An- und Abhängens einer jeden einzelnen Arzneimitteleinheit 4 und wertet diese Daten aus. Ebenso tauscht sie Daten mit der Datenbank 6 aus und verarbeitet diese Daten. Mit dem Ergebnis dieser Datenverarbeitung wird die Verschlusseinheit 1 gesteuert;
• – eine Verschlusseinheit 1 für einen Verschluss 1a, der zum Schließen und Öffnen der flüssigkeitsdurchströmbaren Verbindung geeignet ist. Die flüssigkeitsdurchströmbare Verbindung befindet sich zwischen der Arzneimitteleinheit 4 und dem Patienten 20.

The device according to the invention for preventing incorrect delivery of drugs comprises at least the following components:

• - a readout unit 3 for collecting the data of the identification means 9 of the patient 20 and the identification means 7 the drug unit 4 and for forwarding this data to the control unit 2 ;
• A contact measuring means 8th for autonomous detection of whether a drug unit 4 on a drug delivery device 5 is coupled and for forwarding this data to the control unit 2 , The contact measuring device 8th thus autonomously detects each attachment and detachment (every change) of a drug unit 4 that is, it detects the docking of a drug unit 4 ;
• - a control unit 2 for collecting and evaluating the data of the readout unit 3 , for the collection and evaluation of the data of the contact measuring device 8th , to exchange data with a database 6 and for processing this data as well as for controlling the closure unit 1 , The control unit 2 thus captures the data of the means of identification 9 of the patient 20 , the data of the means of identification 7 the drug unit 4 as well as the data of the contact measuring device 8th concerning each attachment and detachment of each individual drug unit 4 and evaluates this data. Likewise, it exchanges data with the database 6 and processes this data. The result of this data processing becomes the shutter unit 1 controlled;
• - a closure unit 1 for a closure 1a which is suitable for closing and opening the liquid-throughflowable connection. The liquid-permeable compound is located between the drug unit 4 and the patient 20 ,

• – das Kontaktmessmittel 8 das Angekoppeltsein einer Arzneimitteleinheit 4 an der Arzneimittelverabreichungsvorrichtung 5 erfasst und diese Daten an die Steuereinheit 2 weitergeleitet hat,
• – und wenn die Ausleseeinheit 3 die Daten der Identifikationsmittel 7 und 9 erfasst und an die Steuereinheit 2 weitergeleitet hat,
• – und wenn die Steuereinheit 2 die weitergeleiteten Daten mit den Daten der Datenbank 6 abgeglichen und eine Kompatibilität zwischen den Daten der Identifikationsmittel 7 und 9 festgestellt hat.

The control unit 2 acts on the locking unit 1 that the shutter 1a in principle, the liquid-permeable compound closes. The control unit 2 acts on the locking unit 1 that the shutter 1a the liquid-permeable compound opens only if:

• - the contact measuring means 8th the coupling of a drug unit 4 at the drug delivery device 5 captured and this data to the control unit 2 has forwarded,
• - and if the elite unit 3 the data of the identification means 7 and 9 captured and sent to the control unit 2 has forwarded,
• - and if the control unit 2 the forwarded data with the data of the database 6 adjusted and compatibility between the data of the identification means 7 and 9 Has been established.

These components according to the invention are arranged relative to one another such that the contact measuring means 8th the information of attaching or detaching a drug unit 4 on a drug delivery device 5 to the control unit 2 transmitted, and that the control unit 2 the closure unit 1 so controls that the flow of a drug through the liquid-flowable compound from the drug unit 4 to the patient 20 is interrupted or released.

The device of the invention is adapted to be attached to a drug delivery device 5 attachable.

Furthermore, the device according to the invention is designed such that the opening or closing of the liquid-throughflowable connection between the drug unit 4 and the patient 20 after evaluation of all recorded data by the control unit 2 depending on whether a compatible or incompatible medicinal product is present.

readout unit 3 : Device for detecting the identification means 7 and 9 data and for forwarding this data to the control unit 2 , It comprises at least one sensor for detecting this data, which are present for example in the form of electromagnetic and / or acoustic signals. The elite unit 3 can both the data of the means of identification 7 the drug unit 4 read as well as the data of the means of identification 9 of the patient 20 ,

The elite unit 3 In one embodiment, the patient identification means already known in the medical field 9 such as patient identification arm or foot band with barcode, Eurocode or ISBT code. The elite unit 3 can be a scanner such as a barcode scanner (ISBT barcode, Eurocode), a Camera or other suitable device.

The elite unit 3 passes the data to the control unit 2 wirelessly (for example by radio or as a visual or audible signal) or wired.

In an optional embodiment, the control unit 2 and the elite unit 3 designed as a component. In that case, the control unit 2 directly the data of the means of identification 7 the drug unit 4 and the data of the means of identification 9 of the patient 20 to capture.

identification means 7 and 9 : Identification means are used both for the unique, permanent and distinctive labeling of a drug in a drug unit (identification means 7 ) as well as for the clear and unmistakable identification of a patient (identification means 9 ).

In the case of a transfusion, the means of identification serves 7 for the clear, permanent and unmistakable identification of a blood product in a transfusion unit. In the case of an infusion, the means of identification serves 7 for the clear, permanent and unmistakable identification of an infusion solution in an infusion unit.

The means of identification 7 to identify a drug unit is a device on or on a drug unit, such as a label or a bar code or a bill of lading.

The means of identification 9 To identify a patient is, for example, the medical record or a barcode on an arm or foot strap or a smart card. The identification means 7 and 9 contain data by the readout unit 3 or directly through the control unit 2 can be detected.

Transfusion Unit 4 : The transfusion unit is a special form of a drug unit 4 , It is any unit of a blood product (eg of blood components) that is transfused into a patient (human or animal). Blood products are medicines intended for transfusion in patients (humans or animals). The transfusion unit thus comprises the blood product with its packaging (eg blood bag). At the transfusion unit is an identification means 7 attached. This includes, for example, the consignment note (conservational note, issue slip), which uniquely, permanently and unmistakably characterizes the blood product and thus each transfusion unit.

infusion unit 4 : The infusion unit is a special form of a drug unit 4 , It is any unit of infusion solution (eg, a patient-specific composition of antibiotic or chemotherapeutic agent) that is infused into a patient (human or animal). Infusion solutions are medicines intended for infusion into patients (humans or animals). The infusion unit thus comprises the infusion solution with its packaging (eg infusion bag or infusion bottle). At the infusion unit is an identification means 7 attached, for example, a label containing information on the composition of the infusion solution. The means of identification 7 but can also be a consignment note (issue slip), which identifies each patient-specific infusion solution and thus each infusion unit clearly, permanently and unmistakably.

Contact measuring equipment 8th : The contact measuring device 8th is a mechanical or electronic device suitable for attaching and detaching a drug unit 4 ie the production (by coupling) or the interruption (by decoupling) of a fluid-permeable compound from the drug unit 4 to the patient 20 to record autonomously. In particular, the contact measuring means detects 8th the attachment and detachment of a transfusion unit to the transfusion device or the attachment and detachment of an infusion unit to the infusion device. The contact measuring device 8th sends data from the control unit 2 can be received and evaluated, for example in the form of electromagnetic and / or acoustic signals. The transmission of the data can be wired or wireless (eg by radio). Alternatively, the contact measuring means transmits 8th the data collected by him first to the readout unit 3 from where the data to the control unit 2 to get redirected.

The contact measuring device 8th is in size and shape to the dimensions of the drug unit 4 adaptable, for example by means of a set screw or a clamp or a spring.

The contact measuring device 8th serves to provide information about attaching and detaching a drug unit 4 to record autonomously and to the control unit 2 continue to lead. The contact measuring device reports 8th to the control unit 2 autonomously with each change of the drug unit, the coupling of the drug unit 4 at the drug delivery device 5 , The contact agent 8th in the case of a transfusion or infusion serves to detect both attachment of the transfusion / infusion unit to the transfusion / infusion device and suspension of the transfusion / infusion unit from the transfusion / infusion device, regardless of which blood product or infusion solution is itself in the respective Transfusion / infusion unit is located. This information is then sent to the control unit 2 passed on. If, for example, within the scope of a transfusion series first a blood product is transfused (eg red blood cell concentrate) and then another blood product (eg fresh plasma), then the device according to the invention autonomously compares the data of the identification means with each new transfusion unit 7 the transfusion unit 4 and the data of the means of identification 9 of the patient 20 as well as the data of the database 6 carried out. If it detects an incompatibility, then the shutter remains 1a closed, so that the transfusion can not be started. If a compatibility is detected, then controls the control unit 2 the closure unit 1 so that the shutter 1a is opened. Similarly, the control unit controls 2 the closure unit when performing an infusion or generally when delivering a drug.

The contact measuring device 8th may be a contact mechanism, for example in the form of a clip. The contact measuring device 8th detects by means of a switching function the attachment and detachment of the drug unit 4 and passes this information to the control unit 2 further. This will be the control unit 2 when attaching a drug unit 4 for a new acquisition of the data of the identification means 7 the drug unit 4 and the data of the means of identification 9 of the patient 20 initiates and compares this data.

control unit 2 : Device for detecting and evaluating the readout unit 3 and / or the contact measuring means 8th generated data, to exchange data with the database 6 , to process this data and to control the locking unit 1 with the lock 1a , The control unit 2 receives the data of the readout unit 3 , the data of the contact measuring means 8th and the data of the database 6 , It processes this data and controls the locking unit 1 , Optionally, the control unit initiates 2 Data to the database 6 ,

The control unit detects by means of the contact measuring means 8th generated data, whether a drug unit 4 was attached or appended (that is, the coupling of a drug unit 4 ). The control unit 2 compares the data of the means of identification 7 the drug unit 4 with the data of the means of identification 9 of the patient 20 , In the case of a transfusion, the control unit compares 2 the data on the blood groups of the patient 20 with the data on the blood groups and the shelf life of the blood product in the respective transfusion unit 4 , The control unit has access to a database 6 with data on all patients and on all medicines (including all blood products) registered in the medical institution concerned. Alternatively, the control unit 2 yourself a database 6 containing data on all patients and on all medicinal products (including all blood products) registered in the medical establishment concerned. The control unit 2 includes means for comparing the data of the patient with the data on the medicinal products and means for evaluating this data.

The control unit serves to control the closure unit 1 with the lock 1a , The control unit 2 opens the lock 1a only if the data of the means of identification 9 of the patient 20 with the data of the means of identification 7 the drug unit and the data from the database 6 match and provide compatibility. In the case of a transfusion / infusion gives the control unit 2 the blood product / infusion solution only free if the data of the means of identification 9 of the patient 20 with the data of the means of identification 7 the transfusion / infusion unit and the data from the database 6 and compatibility, and if the shelf life of the blood product / infusion solution in question has not yet expired. The control unit 2 autonomously blocks the administration of a drug if the data of the means of identification 9 of the patient with the data of the means of identification 7 of the drug unit or if the shelf life of the medicinal product in question has expired (ie if there is a risk of incompatibility).

The control unit 2 receives via the readout unit 3 Data of identification means 7 and 9 as well as data from the contact agent 8th , From this data, the control unit recognizes 2 whether there is a compatible or incompatible drug in the respective drug unit 4 located. Depending on this, the control unit decides 2 every time you disconnect and attach, whether the closure 1a remains closed or is opened and thus releases the supply of the drug via the flüssigkeitsdurchströmbare compound.

In the case of a transfusion / infusion thus detects the control unit 2 autonomously all data of the blood product to be transfused, for example its blood groups and the expiration date or all data of the infusion solution to be infused. The data of the patient 20 , in particular the data on his blood groups are determined by the readout unit 3 from the patient identification means 9 (eg a bracelet with a barcode). Alternatively, it is also possible that the patient's data 20 , in particular the data on his blood groups directly from the control unit 2 from the patient identification means 9 (eg a bracelet with a barcode). Alternatively, it is also possible to enter the data of the Patients, especially the data on his blood groups manually in the control unit 2 enter.

The control unit 2 is located anywhere on or near the patient 20 , the drug unit 4 and the drug delivery device 5 ,

The control unit 2 is from contact measuring means 8th about each attachment of a drug unit 4 , every hanging of a drug unit 4 and each re-attachment of a drug unit 4 autonomously informed, even if this detachment and attachment in a series, such as a series of transfusions directly following each other, or if the same drug unit 4 first be hung up and then attached again. Each attachment and appending causes the control unit 2 autonomously to a re-evaluation of the collected data to the patient concerned 20 and to the respective drug unit 4 (which contains, for example, a blood product or an infusion solution). This ensures that even in hectic situations, where the attention of the medical employee under certain circumstances otherwise claimed, a misfeed of a drug is reliably prevented because at one by the control unit 2 incompatibility detected autonomously the delivery of the drug through the closure 1a the locking unit 1 stopped or not started.

shutter unit 1 : Device for closing (blocking, interrupting) and opening (releasing) the liquid-throughflowable connection between the drug unit 4 and the patient 20 , The closure unit 1 either prevents the delivery of the drug from the drug unit 4 to the patient or allows delivery of the drug from the drug unit 4 to the patient 20 , By default, the locking device stops 1 the lock 1a closed, so no drug in the patient 20 can get. Only if the control unit 2 all conditions for the opening of the closure 1a as satisfied detects, then controls the control unit 2 the closure device 1 so that the shutter 1a is opened.

The closure unit 1 has at least one closure 1a For example, a valve, a magnetic closure or a roller clamp, which is adapted to the liquid-permeable connection between the drug unit 4 and the patient 20 to close or open. The closure unit 1 is to the drug delivery device 5 coupled and is controlled by the control unit 2 controlled. Depending on the control by the control unit 2 closes or opens the locking unit 1 autonomously the flow (the supply) of the drug from the drug unit 4 via the fluid-permeable connection to the patient 20 ,

The closure unit 1 autonomously prevents the supply of a drug, if after the autonomous comparison of the data of the identification means 7 and 9 with the data of the database 6 through the control unit 2 an incompatibility by the control unit 2 is detected. As a result, transfusion or infusion series are monitored in a preferred manner, since the contact measuring means 8th each detachment and appendage of a drug unit 4 recognizes. This information is provided by the contact measurement means 8th captured and sent to the control unit 2 Posted. The control unit 2 Then leads with each detachment and attachment process (coupling and uncoupling of the drug unit 4 when changing) a new data match between the data of the identification means 7 and 9 with the data of the database 6 by. As a result, closes or opens at each disconnect and attach the closure unit 1 with the lock 1a the fluid-permeable compound and thus the flow of the drug.

The closure unit 1 is located at a location of the drug delivery device 5 at which the drug administration (for example, the transfusion or the infusion) can be mechanically stopped, ie between the drug unit 4 and the patient's venous indwelling catheter 20 ,

The closure 1a may be, for example, a magnetic closure, the drug delivery device from the outside 5 so closes that the medicine can not flow. The magnetic closure comprises a magnet which can be switched on and off and an abutment on which this magnet can act. In the basic setting (closed shutter 1a ) press the magnet and / or the abutment from the outside to the drug administration device 5 and thus occlude the liquid-permeable compound. Only if the control unit 2 has established compatibility, then the shutter 1a opened and thus the flow released for the drug to be administered.

So if a intended for administration drug unit 4 to the drug delivery device 5 attached, then by the contact measuring means 8th this process is registered autonomously and sent to the control unit 2 reported. The control unit 2 then autonomously checks the from the readout unit 3 collected data on the patient concerned 20 (For example, about the means of identification 9 on the medical record or the arm or foot band) and to the respective drug (for example via the means of identification 7 on the drug unit 4 ). That is, the control unit 2 the compatibility of the patient 20 Autonomously checked with the drug.

Represents the control unit during this check 2 an incompatibility then controls the control unit 2 autonomous the locking unit 1 and holds the lock 1a closed. This autonomously prevents the supply of the drug. Represents the control unit during this check 2 a compatibility, then controls the control unit 2 autonomous the locking unit 1 and opens the lock 1a , This autonomously allows the supply of the drug.

When the contact measuring means 8th the hanging off of a drug unit 4 from the drug delivery device 5 captured and this data to the control unit 2 forwards, then gives the control unit 2 autonomous to the locking unit 1 the control command, the lock 1a close, so that the shutter 1a is back in his basic attitude.

In one embodiment, the closure becomes 1a realized in that a transfusion machine is closed or opened, or that an infusion or perfusion pump off or be turned on. In another embodiment, the closure becomes 1a by a mechanical blockage of the drug delivery device 5 realized. This mechanical blockage can be anywhere on the drug delivery device 5 take place, ie between the drug unit 4 and the patient's venous indwelling catheter 20 ,

The control unit 2 equals the data of the means of identification 7 and 9 with the data of a database 6 from. This can be z. B. the database of the hospital, where the individual patent data such as blood type, drug intolerances, allergies and the like are stored. Database 6 can also be an internal memory of the control unit 2 be. In the database 6 can also manually z. B. data are entered before the start of a transfusion series. That is also possible if the database 6 an internal memory of the control unit 2 is.

In a further embodiment, the device has an optical and / or acoustic and / or haptic signal transmitter 10 on. In the case of incompatibility, this serves to output an optical or acoustic or haptic alarm signal. The alarm alerts medical staff to the incompatibility.

The transmission of data between the contact measuring means 8th , the means of identification 7 and 9 , the elite unit 3 , the control unit 2 , the database 6 , the lock 1 and the signal generator 10 Can be wired or wireless, z. B. by radio.

In a preferred embodiment, the supplied drug is a blood product or an infusion solution, the device thus prevents the misinsertion of a blood product or the misinsertion of an infusion solution, so it prevents false transfusions or Fehlinfusionen.

In one embodiment, the device of the invention autonomously prevents false transfusions, even if the patient blood groups are not yet known, for example in emergency care in the trauma room, during operations or in the intensive care unit or in the absence of a patent identification means 9 , In these emergency situations, the control unit 2 programmed so that only after attaching a AB0 universal contractual blood product (for example, erythrocyte concentrate with the blood group 0), the closure unit 1 with the lock 1a the supply (flow) of the blood product from the transfusion unit 4 to the patient releases. So if there is no data on the patient's blood groups, then the control unit gives 2 over the locking unit 1 exclusively AB0 universal blood products for transfusion free. Thus, even in emergency mode (shock room, during critical operations), the invention autonomously prevents false transfusion due to AB0 incompatibility.

The device according to the invention preferably monitors not only the compatibility of erythrocyte concentrate or whole blood with regard to ABO blood group compatibility, but also autonomously the compatibility of all blood products with respect to all blood groups.

The device according to the invention does not require any medical knowledge of the employee with regard to possible incompatibilities, which is particularly advantageous in hectic situations or in the event of a shortage of personnel.

The device according to the invention not only autonomously monitors the first attachment of a drug unit 4 (Experience has shown that this is done with the utmost care), but continuously and autonomously the entire course of a series of several drug units 4 including any hanging and attaching. This preferably relates to a transfusion series, ie the attachment and detachment of more than one drug unit 4 containing a blood product. In that case becomes the drug unit 4 also transfusion unit 4 called. Similarly, an infusion series is monitored. In that case, the drug is an infusion solution and the drug unit 4 becomes infusion unit 4 called.

This monitoring of series is done by the contact measuring equipment 8th ensures that every drug unit (eg transfusion unit or infusion unit) 4 serves. This is particularly useful because it can happen in hectic emergency situations that an unauthorized person a wrong drug unit 4 appends. The device according to the invention thus continuously monitors the venous access of the patient 20 (Venous indwelling catheter), over which the drug delivery is running.

The device according to the invention also autonomously monitors the shelf life of the drug to be delivered (administered) to the patient. In a preferred embodiment, the device according to the invention autonomously monitors the durability of the blood product to be transfused or of the infusion solution to be infused. This is done by reconciling the information about durability on the means of identification 7 through the control unit 2 guaranteed. Thus, the device according to the invention also autonomously prevents false transfusion or misinterfusion when the shelf life of the blood product or infusion solution has expired. This relates both to the shelf life of the blood product or the infusion solution in general, as well as to the shelf life of blood products or infusion solutions that must be stored refrigerated while maintaining the cold chain.

The device according to the invention can be combined with electronic or paper-based methods for patient identification already known in the medical field (for example patient arm or foot band, bedside test for AB0 blood group typing, patient identification numbers for documentation systems), but can also be used independently of this.

The known drug delivery devices, such as transfusion machines, infusion, perfusion or transfusion pumps can be converted by minor technical changes so that the device of the invention can be used immediately.

• 1. Feststellen des Angekoppeltseins einer Arzneimitteleinheit 4 an der Arzneimittelverabreichungsvorrichtung 5 durch ein Kontaktmessmittel 8;
• 2. Erfassen der Daten des Identifikationsmittels 7 der Arzneimitteleinheit 4 durch die Ausleseeinheit 3;
• 3. Erfassen die Daten des Identifikationsmittels 9 des Patienten 20 durch die Ausleseeinheit 3;
• 4. Weiterleitung der Daten aus den Schritten 1, 2 und 3 an die Steuereinheit 2;
• 5. Verarbeitung der Daten aus den Schritten 1, 2 und 3 in der Steuereinheit 2;
• 6. Austausch der verarbeiteten Daten aus Schritt 5 zwischen der Steuereinheit 2 und der Daten der Datenbank 6;
• 7. Abgleich der ausgetauschten Daten aus Schritt 6 und Feststellung ob eine Kompatibilität vorliegt;
• 8. Steuerung der Verschlusseinheit 1 mit dem Verschluss 1a durch die Steuereinheit 2;

The method according to the invention for preventing misfires of medicaments comprises the following steps:

• 1. Detecting the docking of a drug unit 4 at the drug delivery device 5 through a contact measuring means 8th ;
• 2. Acquire the data of the identification means 7 the drug unit 4 through the readout unit 3 ;
• 3. Collect the data of the identification means 9 of the patient 20 through the readout unit 3 ;
• 4. Forward the data from steps 1, 2 and 3 to the control unit 2 ;
• 5. Processing the data from steps 1, 2 and 3 in the control unit 2 ;
• 6. Exchange the processed data from step 5 between the control unit 2 and the data of the database 6 ;
• 7. Matching the exchanged data from step 6 and determining if compatibility exists;
• 8. Control of the closure unit 1 with the lock 1a through the control unit 2 ;

In an alternative embodiment, the data exchange between the control unit 2 and the database 6 each administration of a drug unit 4 be automatically documented in the relevant patient record of the patient. This additional process step allows for easy quality control in drug delivery, especially when performing transfusions or infusions. This method step also simplifies the billing of the drug administration performed by the medical institution with the cost unit, in particular the transfusion or infusion. This method step also facilitates a scientific evaluation of the drug administration performed, in particular the transfusion or infusion.

Explanation of the figure

The device according to the invention will be explained in more detail with reference to the accompanying drawing.

1 shows a side view of an embodiment of the device according to the invention.

The control unit 2 acts on the locking unit 1 that this is the closure 1a closed (basic setting of the shutter 1a ). The control unit 2 controls the locking unit 1 that is, the closure unit 1 receives from the control unit 2 Control commands. Only if the locking unit 1 from the control unit 2 the control command to open the shutter 1a receives, opens the lock unit 1 the lock 1a , The closure 1a For example, it may be a valve, in particular a solenoid valve, a magnetic closure, a roller clamp, a tap or a three-way cock. The closure 1a may also be a bolt or a similar mechanical component, which is arranged so that it by pressure on the The drug delivery device 5 from the outside the flow of the drug within the drug delivery device 5 in derogation. This stop of flow is preferred at the portion of the drug delivery device 5 performed, which is referred to as a transfusion tube or infusion tube. However, stopping the flow of the drug may also be at any other location on the drug delivery device 5 be performed. It is also possible that the locking unit 1 closes a transfusion machine or turns off an infusion or perfusion pump. The closure unit 1 put on the lock 1a the control commands of the control unit 1 around. The closure unit 1 and the control unit 2 are connected via a radio link (wireless) or a data cable (wired) so that the control unit 2 a control command to the closure unit 1 can transmit. The closure unit 1 is arranged to control the flow of the drug through the drug delivery device 5 can interrupt.

In a preferred embodiment, the drug is a blood product or an infusion solution. The drug unit 4 is called in these cases, transfusion or infusion unit. The drug delivery device 5 is called in these cases, transfusion or infusion device.

The transfusion or infusion unit 4 contains the blood product to be transfused or the infusion solution to be infused. At the transfusion or infusion unit 4 is it z. A bag or bottle or syringe or other suitable container for blood products or infusions and the blood product to be transfused or the infusion solution to be infused (eg erythrocyte concentrate, blood plasma or infusion with chemotherapeutic agents). Attached to it, usually glued, is the identification device 7 for identification of the transfusion or infusion unit 4 and with data on the blood product or infusion solution in the transfusion or infusion unit 4 , The means of identification 7 can be a barcode, an RFID chip or something similar.

The means of identification 7 allows the unique identification of the blood product in the transfusion unit 4 or the infusion solution in the infusion unit 4 , The data of the means of identification 7 be from the elite unit 3 captured, either by the means of identification 7 Active the data to the readout unit 3 sends, or by the read-out means 3 the means of identification 7 reads. The reading device 3 can z. B. be a radio receiver or an optical scanner.

In an optional embodiment, the control unit 2 and the elite unit 3 designed as a component. In that case, the control unit 2 directly the data of the means of identification 7 the drug unit 4 and the data of the means of identification 9 of the patient 20 to capture. In this case, the data of the identification means will be 7 and 9 directly from the control unit 2 captured, either by the means of identification 7 and 9 actively send the data to the control unit 2 send, or by the control unit 2 the means of identification 7 and 9 reads.

The contact measuring device 8th serves to detach and attach a drug unit 4 determine autonomously, ie the contact of the drug unit 4 with the drug delivery device 5 to recognize autonomously. As a contact measuring means may serve an electrically conductive clip, in which when attaching the drug unit 4 to the drug delivery device 5 a circuit closes, which one from the control unit 2 evaluable signal triggers. When hanging out then by opening the circuit again one of the control unit 2 evaluable signal triggered. Alternatively, the contact measuring means transmits 8th this data directly to the control unit 2 , The transmission of this data can take place via a radio link (wireless) or a data cable (wired).

The contact measuring device 8th but may also be implemented in another suitable form, for. B. as a magnetic connection, spring mechanism, etc. It is essential only that the contact measuring means 8th the coupling of a drug unit 4 at the drug delivery device 5 determines and this information to the control unit 2 forwards.

The control unit 2 receives via the readout unit 3 or directly the data of the means of identification 7 on the drug unit 4 , the data of the means of identification 9 of the patient 20 and the data of the contact measuring means 8th , When the contact measuring means 8th signals that the drug unit 4 with the drug delivery device 5 is connected, then compares the control unit 2 the data from the identification means 7 the drug unit 4 with the data from the identification means 9 of the patient 20 and the data of the database 6 ,

In a preferred embodiment, the drug unit is 4 around a transfusion unit and the control unit 2 compares the data from the identification means 7 with the data from the identification means 9 of the patient 20 and the data of the database 6 in particular with regard to the blood group compatibility of the blood product to be administered.

In another preferred embodiment, the drug unit is 4 around a transfusion or infusion unit and the control unit 2 compares the data from the identification means 7 with the data from the identification means 9 of the patient 20 and the data of the database 6 in particular with regard to the durability of the blood product to be administered or the infusion solution to be administered.

Only if the control unit 2 due to this data comparison, a compatibility between the data of the identification means 7 and 9 with the data of the database 6 determines, then gives the control unit 2 to the closure unit 1 the control command, the lock 1a to open. Only then does the drug, such as the blood product or infusion solution, flow through the drug delivery device 5 in the patient 20 , This data comparison thus autonomously checks the compatibility of the blood product in the transfusion unit 4 or the infusion solution in the infusion unit 4 with the respective patient 20 ,

If the control unit 2 due to this reconciliation an incompatibility between the data of the identification means 7 and 9 and the data of the database 6 determines, then gives the control unit 2 to the closure unit 1 the signal, the shutter 1a not to open but to keep it closed. Then, no drug, for example, the blood product or the infusion solution, flows through the drug administration device 5 in the patient and a misinsertion, for example, a false transfusion or misinfection is autonomously prevented.

To make sure that the medically prescribed drug unit 4 to the drug delivery device 5 attached, it makes sense to use even more sources of information. Thus, the device comprises a patient-affixable patient identification means 9 (eg arm or foot strap with bar code strip or RFID chip). The data of the patient identification means 9 be from the elite unit 3 detected, to the control unit 2 passed on and from the control unit 2 processed. Alternatively, the data of the patient identifier 9 also directly from the control unit 2 be recorded.

The acquisition of the data of the contact measuring means 8th as well as the data of the identification means 7 and 9 and the processing of this data in the control unit 2 and the comparison with the data of the database 6 allow a comparison of whether the right patient is getting the right drug, especially the right blood product or solution.

By accessing a database 6 can the control unit 2 a faster allocation of the drug unit 4 to the respective patient 20 make. Likewise, by the control unit 2 any drug delivery on the database 6 documented, which is advantageous for quality control, medical billing and scientific evaluation. This is especially true for transfusions or infusions.

Furthermore, the device can still be a signal generator 10 include. This emits an optical and / or acoustic and / or haptic signal when the control unit 2 an incompatible drug unit 4 at the drug delivery device 5 finds. By the signal of the signal generator 10 the medical staff is prompted to check the compatibility of the drug unit 4 with the patient 20 and, if there is an incompatibility, the drug unit thus identified as being incompatible 4 to remove. The signal generator 10 is therefore suitable for the responsible staff to the presence of an incompatible drug unit 4 display.

LIST OF REFERENCE NUMBERS

1

shutter unit

1a

shutter

2

control unit

3

readout unit

4

drug unit

5

The drug delivery device

6

Database

7

Identification means of the drug unit

8th

Contact measuring equipment

9

Identification means of the patient

10

signaler

20

patient

Claims (7)

Device for preventing a misfeed of a drug via a liquid-permeable compound from the drug unit ( 4 ) to the patient ( 20 ) attachable to a drug delivery device ( 5 ), comprising - a read-out unit ( 3 ) for collecting the data of the identification means ( 7 ) of the drug unit ( 4 ) and the identification means ( 9 ) of the patient ( 20 ) and to forward this data to the control unit ( 2 ), - a contact measuring means ( 8th ) for detecting whether a drug unit ( 4 ) on a drug delivery device ( 5 ) and to forward this data to the control unit ( 2 ), - a control unit ( 2 ) for collecting and evaluating the data of the readout unit ( 3 ), for the acquisition and evaluation of the data of the contact measuring means ( 8th ), to exchange data with a Database ( 6 ) and for the processing of this data and for the control of the closure unit ( 1 ) and - a closure unit ( 1 ) for a closure ( 1a ), which is suitable for closing and opening the liquid-throughflowable connection, characterized in that the control unit ( 2 ) so on the closure unit ( 1 ) acts that the closure ( 1a ) is opened only when - the contact measuring means ( 8th ) the coupling of a drug unit ( 4 ) at the drug delivery device ( 5 ) and transmit this data to the control unit ( 2 ), and - if the readout unit ( 3 ) the data of the identification means ( 7 ) and ( 9 ) and to the control unit ( 2 ), and - if the control unit ( 2 ) the forwarded data with the database data ( 6 ) and a compatibility between the data of the identification means ( 7 ) and ( 9 ) Has been established. Apparatus according to claim 1, characterized in that the readout unit ( 3 ) is a barcode scanner (ISBT, Eurocode) or a camera. Apparatus according to claim 1 or 2, characterized in that the contact measuring means ( 8th ) is a clip, a spring mechanism, a magnetic connection or a light barrier. Device according to one of the preceding claims, characterized in that the closure unit ( 1 ) a closure ( 1a ). Device according to claim 4, characterized in that the closure ( 1a ) is a magnetic shutter, a roller clamp, a tap, a three-way cock or a valve. Device according to one of the preceding claims, characterized in that the drug unit ( 4 ) comprises a blood product or an infusion solution. Device according to one of the preceding claims, characterized in that it comprises at least one optical and / or acoustic and / or haptic signal generator ( 10 ) for outputting an optical and / or acoustic and / or haptic alarm signal in the absence of compatibility.

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